Endologix Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to commence a confirmatory clinical study evaluating the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System (EVAS) for the endovascular treatment of infrarenal abdominal aortic aneurysms. The EVAS2 IDE Multicenter Safety and Effectiveness Confirmatory Study (EVAS2) will prospectively evaluate the refined Indications for Use (IFU) and the Nellix Gen2 EVAS System.

The Role of Telomere Length in Cardiovascular Risk Assessment

A new area of DNA testing involving telomere length may enhance a patient’s cardiovascular disease risk stratification.  Telomeres are biological clocks that determine the lifespan of a cell, as well as the number of times it can divide to create replacements. Telomeres are repeating units of DNA on the ends of each chromosome that protect the information encoded in the DNA against loss. Some of these repeating units are lost with each cell division, but can be restored by enzymes in the nucleus.  

October 18, 2017 — The U.S. Food and Drug Administration (FDA) recently approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea (CSA). The  Respicardia Remedē System is an implantable pacemaker-like device that stimulates the phrenic nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.

Magnetic resonance imaging (MRI)-based measurements of the functional connections in the brain can help predict long-term recovery in patients who suffer neurological disability after cardiac arrest, according to a study appearing online in the journal Radiology.

October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the Xarelto vascular dose plus aspirin 100 mg once daily significantly reduced the risk of major cardiovascular events by 24 percent in patients with stable coronary and/or peripheral artery disease (CAD/PAD) compared to aspirin alone. This finding was driven by a robust 42 percent reduction in any stroke and 22 percent reduction in cardiovascular (CV) death.

Baylis Medical Co. Inc. and Siemens Healthineers are co-sponsoring a first-of-its kind training program aimed at helping cardiologists perform a complex procedure that is quickly becoming the gold standard for treating patients with atrial fibrillation and other structural heart diseases.

The American College of Cardiology and the American Heart Association recently released updated clinical performance and quality measures to benchmark and improve the quality of care for adult patients hospitalized with ST-elevation and non–ST-elevation myocardial infarction (STEMI and NSTEMI, respectively).

October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S. arm of the ALIVE pivotal clinical trial.

The American College of Cardiology (ACC), along with several partnering societies, recently released appropriate use criteria addressing the evaluation and use of multimodality imaging in the diagnosis and management of valvular heart disease.

October 16, 2017 — Zoll Canada, a subsidiary of Zoll Medical Corp., announced it has won the tender to equip all ambulances in the Province of Quebec with the Zoll X Series Monitor/Defibrillator. The purchase of 866 X Series was negotiated by GACEQ (Groupe d’approvisionement en commun de l’Est Qué).

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